Status:
COMPLETED
Safety and Efficacy of Enteric-coated Mycophenolate Sodium (EC-MPS) Plus Valsartan in Patients With Kidney Transplants (MYTHOS
Lead Sponsor:
Novartis
Conditions:
De Novo Renal Transplantation
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The primary aim of this study is to evaluate the safety and efficacy of EC-MPS plus valsartan as part of an intensified multifactorial intervention on the reduction of the 12-month rate of transplant ...
Eligibility Criteria
Inclusion
- Inclusion criteria
- 1\. Male and female patients aged 18 to 70 years 2. Patients receiving a first kidney transplant from a cadaver donor, who are scheduled to receive CsA-ME and anti-CD25 antibody as primary immunosuppression; 3. Patients able to receive the first dose of EC-MPS within 48 hours of graft reperfusion Exclusion criteria
- Multi-organ recipients (e.g. kidney and pancreas, double kidney) or previous transplant with any other organ.
- Recipient of a kidney from a non-heart beating, from a cadaver donor aged more than 70 years, or with cold ischemia time of more than 36 hours
- Recipient who is HLA-identical to the donor
- Patients with a PRA level (past or current level) higher than 50%
- Patients with a known hypersensitivity to EC-MPS or other components of the formulation (e.g. lactose).
- Patients with thrombocytopenia (\< 75,000/mm3), with an absolute neutrophil count of \< 1,500/mm3, and/or leukocytopenia (\< 2,500/mm3), and/or hemoglobin \< 6 g/dL at Screening or Baseline.
- HIV-positive
- Positive HBsAg test for both donor and recipients.
- Unstable angina, acute myocardial infarction or stroke during the last 6 month or heart failure NYHA class III-IV or hemodinamically significant valvular heart disease
- Liver injury as indicated by transaminase serum levels (ALT and/or AST) greater than 2 x ULN
- Creatinine kinase (CK) levels greater than 5 x ULN. Additional protocol-defined inclusion/exclusion criteria may apply
Exclusion
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2005
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT00308425
Start Date
October 1 2002
End Date
June 1 2005
Last Update
January 31 2011
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